FDA Adverse Event
Injury
Summary report: N
LINEAR? ST
MDR report key: 23030447
·
Received September 11, 2025
Report
- Report Number
- 3006630150-2025-07496
- Event Type
- Injury
- Date Received
- September 11, 2025
- Date of Event
- July 18, 2025
- Report Date
- December 10, 2025
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
- Product Code
- LGW
- UDI-DI
- 08714729767749
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2218700. MODEL: SC-2218-70. SERIAL: (B)(6). BATCH: 7093304. UDI: (B)(4).
Description of Event or Problem · 0
IT WAS REPORTED THAT THE LEADS HAD HIGH IMPEDANCES. THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR (SCS) EXPLANT PROCEDURE WHERE THE LEADS WERE REMOVED. THE EXPLANTED DEVICES WILL NOT BE RETURNED. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE PATIENT WAS DOING WELL POSTOPERATIVELY.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE LEADS HAD HIGH IMPEDANCES. THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR (SCS) EXPLANT PROCEDURE WHERE THE LEADS WERE REMOVED. THE EXPLANTED DEVICES WILL NOT BE RETURNED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2644117 | LINEAR? ST | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | SC-2218-70 | 7092381 | 08714729767749 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR | Male | Required Intervention |